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WO2004093732A2 - Protheses de support mobiles - Google Patents

Protheses de support mobiles Download PDF

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Publication number
WO2004093732A2
WO2004093732A2 PCT/US2004/012665 US2004012665W WO2004093732A2 WO 2004093732 A2 WO2004093732 A2 WO 2004093732A2 US 2004012665 W US2004012665 W US 2004012665W WO 2004093732 A2 WO2004093732 A2 WO 2004093732A2
Authority
WO
WIPO (PCT)
Prior art keywords
component
prosthesis
magnetic
magnetic material
dimensioned
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2004/012665
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English (en)
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WO2004093732A3 (fr
Inventor
Edward R. Hyde, Jr.
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Individual
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Individual
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Publication of WO2004093732A2 publication Critical patent/WO2004093732A2/fr
Publication of WO2004093732A3 publication Critical patent/WO2004093732A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
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    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2/3868—Joints for elbows or knees with sliding tibial bearing
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    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
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    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72—Intramedullary devices, e.g. pins or nails
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/60—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements for external osteosynthesis, e.g. distractors, contractors
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    • A61B17/60—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements for external osteosynthesis, e.g. distractors, contractors
    • A61B17/64—Devices extending alongside the bones to be positioned
    • A61B17/6491—Devices extending alongside the bones to be positioned allowing small-scale motion of bone ends
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2/4059—Humeral shafts
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/40—Joints for shoulders
    • A61F2/4081—Glenoid components, e.g. cups
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
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    • A61F2002/30604—Special structural features of bone or joint prostheses not otherwise provided for modular
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    • A61F2250/0001—Means for transferring electromagnetic energy to implants

Definitions

  • the present invention relates to orthopaedic prostheses. More particularly, the present invention relates to orthopaedic prostheses encompassing a self- constraining mobile bearing for maintaining a desired relationship among joint components, thereby reducing friction, wear, deformation, mechanical loosening, and the like.
  • Orthopedics is a medical sub-specialty that treats anatomical disorders related to bones, muscles, ligaments, tendons, joints, and the like.
  • a current emphasis in orthopedics is the treatment of the bones and joints as there is a great need in modern society for bone and joint repair and replacement.
  • the treatment of bone and joint disorders can be generally subclassified into categories including the treatment of bone fractures, joint instability, early stage arthritis, and end stage arthritis.
  • the treatment of orthopedic conditions had mainly relied on casting and bracing.
  • the focus of orthopedics has shifted to become increasingly more of a surgical sub-specialty.
  • Moisdon discloses a method of repositioning body parts through magnetic induction generated by extra-corporeal magnetic or electromagnetic devices. Moisdon also discloses repositioning a degenerated joint to a pre-degenerated state such that the joint tissues can heal. In doing so, magnets are implanted into opposing joint bone portions and adjusted from the exterior of the body. The magnets are adjusted, external to the body, until their repulsive forces create the desired joint orientation.
  • U.S. Patent No. 5,879,386 to Jore describes an apparatus to hold bones apart which can also be adjustable from inside the joint, through arthroscopic means, for example. The disclosed devices and methods have limited uses for specific orthopedic problems.
  • Hyde More recent advancements in orthopaedic prosthesis are disclosed by the present applicant, Hyde, in U.S. Patent No. 6,387,096.
  • Hyde generally discloses the use of magnetic arrays in orthopaedic prosthesis.
  • the disclosed array are arranged to provide composite magnetic fields for locating and confining motion.
  • these designs generally require more complex magnet configurations that may not be suitable or required in all applications.
  • the present invention provides a prosthesis comprises a first component adapted to carry an articulating surface of a joint and a second component, adjacent the first component, configured and dimensioned to be fixed with respect to a bone of the joint. Further included are magnetic elements disposed in each of the first and second components, wherein the magnetic elements cooperate to control motion between the first and second components.
  • a prosthesis of the present invention comprises a first component adapted to carry an articulating surface of a joint and a second component, adjacent the first component, configured and dimensioned to be fixed with respect to a bone of the joint. Also included in this embodiment are physical stops configured and dimensioned around the second component near its perimeter. The stops protrude toward the adjacent first component such that planar movement of the first component with respect to the second component is constrained.
  • the present invention also includes a prosthesis that comprises a first component adapted for operative connection to a first bone portion and a second component adapted for operative connection to a second bone portion opposed to the first bone portion. Magnetic elements are disposed in each of the first and second components to interact with the element in the opposite component. The magnetic elements being configured in a grid pattern with a plurality of oppositely oriented magnetic polarity regions generated thereby. The magnetic elements cooperate to control motion between the first and second components and thus between the first and second bone portions.
  • a prosthesis according to the present invention comprises a first component adapted to carry an articulating surface of a joint and a second component, adjacent the first component, configured and dimensioned to be fixed with respect to a bone of the joint.
  • Magnetic elements are disposed in each of the first and second components. The magnetic elements cooperate to control motion between the first and the second components.
  • the magnetic elements are configured in a grid pattern such that a plurality of opposite oriented magnetic polarity regions are generated. Furthermore, the grid pattern is formed by interlacing a base unit comprised of multiple magnets with polarities oriented such that magnetic flux of the base unit is substantially concentrated on one surface of the base unit.
  • a prosthesis comprises a first component adapted for operative connection to a first bone portion and a second component adapted for operative connection to a second bone portion opposed to the first bone portion.
  • Soft magnetic material is disposed within the first component and hard magnetic material is disposed within the second component.
  • the soft and hard magnetic material being positioned for magnetic attraction therebetween.
  • at least one of the hard or soft magnetic materials has a center point and is configured and dimensioned to vary the magnetic attraction as the opposite magnetic material is moved away from the center point.
  • a prosthesis according to the present invention comprises a first component configured and dimensioned to carry an articulating surface of a joint and a second component configured and dimensioned to interface with the first component on one surface and receive a bone of a joint on an adjacent surface.
  • First magnetic material is disposed within the first component and second magnetic material is disposed within the second component.
  • the second magnetic material is concentrated substantially centrally and around a periphery such that a magnetic attractive gradient is formed between the first component and the second component when the first component translates with respect to the second component.
  • the first magnetic material and the second magnetic material interact to maintain the first component in substantially an equilibrium position with respect to the second component.
  • FIG. 1 A is an exploded, schematic view of an embodiment of a knee prosthesis with a magnetic coupler mobile bearing according to an embodiment of the present invention
  • FIG. IB is a schematic cross section of an alternative mobile bearing according to the present invention
  • FIG. 1 C is a perspective view of a further alternative mobile bearing according to the present invention.
  • FIG. ID is a schematic view of another alternative embodiment of a mobile bearing according to the invention.
  • FIG. 2 is a schematic cross-section of an alternative embodiment of the invention, incorporating the embodiments of FIGS. 1A - ID together in a single device;
  • FIG. 3 is an exploded, schematic view another embodiment of a knee prosthesis with a magnetic coupler mobile bearing according to another embodiment of the present invention
  • FIG. 4 is an exploded, schematic view an embodiment of a shoulder prosthesis with magnetic coupler mobile bearings according to an embodiment of the present invention
  • FIG. 5 is a schematic cross-section showing an embodiment of a magnetic coupler mobile bearing for a prosthesis according to an embodiment of the present invention
  • FIG. 6A is a plan view of a prosthetic component illustrating a distribution of magnetic material according to an embodiment of the present invention
  • FIG. 6B is a plan view of another embodiment of the distribution of material of a magnetic coupler mobile bearing according to another embodiment of the present invention.
  • FIG. 6C is a plan view of yet another embodiment of the distribution of material of a magnetic coupler mobile bearing according to yet another embodiment of the present invention.
  • FIG. 7 A is a schematic view of a further alternative embodiment of the present invention.
  • FIG. 7B is a schematic cross-section showing yet another embodiment of the magnetic coupler mobile bearing of the present invention.
  • FIGS. 8 and 9 are perspective views of a further preferred embodiment of a magnetic coupler mobile bearing according to a further embodiment of the present invention.
  • FIG. 10 is a plan view of an embodiment of a magnetic grid coupler of one component of a mobile bearing according to an embodiment of the present invention.
  • FIG. 11 is a schematic view of a knee prosthetic with a magnetic grid coupler mobile bearing of FIG. 9 incorporated therein;
  • FIG. 12 is schematic view of another embodiment of a mobile bearing according to another embodiment of the present invention.
  • FIG. 13 is a schematic view of yet another embodiment of a mobile bearing according to yet another embodiment of the present invention.
  • FIG. 14 is still another embodiment of a mobile bearing magnetic coupler according to still another embodiment of the present invention.
  • FIG. 1A shows an orthopedic prosthesis 100 for the knee joint according to an embodiment of the present invention
  • Prosthesis 100 includes a first or femoral component 102 having an articular surface 103 and a second or tibial stem component 104.
  • Mobile bearing 101 is disposed between the first and second components and comprises an articulation component 106 and a base component 108.
  • the articulation component 106 and the base component 108 are preferably constructed from approved, implantable articulation materials, such as, ceramics, plastics, metals or, ultra high molecular weight polyethylene, for example.
  • the articulation component 106 is configured with an articulation surface 114 that mates and articulates with articulation surface 103.
  • Prosthesis 100 may be provided as a complete prosthesis itself, or articulation component 106 and base component 108 may be configured to attach to existing tibial stem components 104 and femoral components 102 and articulate with existing or implanted prosthetic articulation surfaces, such as articulation surface 103.
  • Suitable examples of knee prosthesis that articulation component 106 and base component 108 may be adapted to be utilized with is the AMK® made by DePuy Orthopaedics, Inc., Warsaw, Indiana; Ascent® made by Biomet, Inc., Warsaw, Indiana; Genesis II® made by Smith & Nephew, Inc., Memphis, Tennessee; or the like.
  • hard magnetic material 112 is embedded into the articulation component 106.
  • Hard magnetic material 112 is positioned substantially opposite articulation surface 114 of articulation component 106.
  • hard magnetic material 112 is entirely embedded or encased within the articulation component 106, such that no portion of the hard magnetic material is exposed.
  • articulation component 106 be a material that does not interfere with the magnetic flux produced by the hard magnetic material 112.
  • hard magnetic material refers to one or more permanent magnets, permanent magnets having composite structures or materials, or any suitable material that is capable of permanently sustaining a magnetic field.
  • base component 108 is configured to attach to, or be an integral part of typical orthopaedic components that attaches to a bone.
  • the base component 108 is configured to attach to a typical tibial stem component 104 that is configured to be implanted into the tibia of a patient.
  • soft magnetic material 110 Embedded within base component 108 is soft magnetic material 110.
  • soft magnetic material refers to any material, such as iron for example, that is not inherently magnetic, but is capable of sustaining a magnetic field when exposed to a permanent magnet.
  • Magnetic elements Collectively, cooperating magnetic materials, whether hard alone or hard and soft, are referred to herein as "magnetic elements.”
  • Hard magnetic material 112 produces a magnetic flux that attracts the soft magnetic material 110 in the base component 108 to the hard magnetic material 112.
  • articulation component 106 and base component 108 are coupled to each other only by magnetic flux of the hard magnetic material 112, the two components are capable of movement relative to each other, thus forming a mobile bearing 101 through the dynamic constraint of the magnetic flux of the hard magnetic material 112.
  • the articulation component 106 is moveable it will be urged by the magnetic flux to return to a preferred position with the base component 108 when it is displaced during knee function.
  • Mobile bearing 101 thus adds three, controlled degrees of freedom.
  • mobile bearing 101 enables the articulation component 106 to translate in the x-y plane and rotate about the z-axis (FIG. 1A) relative to the base component 108.
  • Control is achieved through the constraint of the magnetic fields.
  • the interaction of the hard and soft magnetic material can be describes as forming a magnetic potential well between the two materials that acts to urge the materials to an equilibrium point, typically defined by a center of the potential well created by the overlapping two materials.
  • one component such as the articulation component 106, can move within the confines of the magnetic potential well without overcoming the confines of the magnetic potential well. The kinetic energy being thus dissipated in the confines of the potential well.
  • the joint containing a prosthesis according to an embodiment of the present invention When the joint containing a prosthesis according to an embodiment of the present invention is articulated, mechanical stresses are generated between components 106 and 108. If these reach a magnitude greater than the potential energy associated with magnetic elements 110 and 112 and the friction, the two components will be displaced out of the potential well. In preferred embodiments, the forces associated with the magnetic elements are not so great, such that, following displacement, the articulation component 106 and the base component 108 can re-align to a substantially preferred position with normal muscular and ligamentous functions. In use, the muscles, tendons, ligaments and similar anatomical structure surrounding the joint apply a sufficient force to substantially re-align the articulation component 106 with the base component 108 following displacement. Preferably, the articulation component 106 may translate between about 0 and +/- 9 mm on the x-y plane relative to the base component 108.
  • Articulation component 106 may also rotate about the z-axis (FIG. 1A) with respect to base component 108.
  • articulation component 106 rotates about base component 108 without a static mechanical constraint.
  • there is no static non-magnetic stop to the rotation about the z-axis which is preferably between about 0 and +/- 90 degrees. Control of the rotation is enabled by the anatomical structures of the particular patient.
  • the magnetic force of the hard magnetic material 112, attracting the soft magnetic material 110 creates a dynamic constraint against rotation similar to that which was described above with respect to translation of the components in the x-y plane.
  • the articulation component 106 can rotate freely within the potential well formed by the hard and soft magnetic material.
  • FIGS. IB- ID illustrate additional building block embodiments that also may be utilized alone or in any combination, including all together, in order to address particular needs.
  • Persons skilled in the art will also recognize the virtually limitless variations that may be made to the basic building block embodiments, only a few examples of which may be reasonably discussed in detail herein, without departing from the scope of the invention. Also, a person of ordinary skill in the art will recognize that the hard magnetic material or the soft magnetic material can be incorporated into either the articulation component or the base component.
  • a mobile bearing of the present invention can consist of one or more levels of movement planes.
  • An example of multiple levels of movement planes includes the articulation component include a base member and an insert member.
  • the insert member being disposed on the base member. Therefore, in this example, the insert member is moveable on the base member while the articulation component is moveable on the base component. Inserting multiple mobile bearing movement planes within a joint decreases transmission of forces to the prosthesis-cement-bone interface. Also, relative thicknesses and surface areas of the magnetic materials may be advantageously manipulated by persons skilled in the art.
  • the soft magnetic material has a tendency to be attracted to the edge of the hard magnetic material instead of the center.
  • the smaller the thickness ratio the greater the tendency will be for the soft magnetic material to be attracted to the edge.
  • the soft magnetic material has a tendency to be attracted to the edge of the hard magnetic material instead of the center. The smaller the surface area ratio, the greater the tendency will be for the soft magnetic material to be attracted to the edge.
  • FIG. IB shows base component 108 in cross section.
  • 108 includes a series of progressively larger zones of soft magnetic material 180, 182, 184 arranged outwardly from the center. These zones may comprise, for example, discrete spots or annular rings. Each zone in conjunction with the hard magnetic material defines a progressively larger magnetic potential well as one moves in an outward direction. Thus, such an arrangement offers an advantage of producing a gradient such that an increasingly larger force for eccentric movement is required and at the same time a decreasingly smaller force for movement back toward a central alignment. [0044] In certain applications, given the particular anatomy of the subj ect j oint and the patient condition, it may be sufficient to constrain motion simply by augmentation of the patient anatomy with one or more magnetic potential wells as described.
  • FIG. 1C illustrates one example of a preferred peripheral stop according to an embodiment of the invention.
  • the base component 108 is configured with a plurality of peripheral posts 150 that provide a structural stop at the limit of travel. Posts 150 protrude beyond the surface of the base component 108 at or near its perimeter such that the articulation component 106 is located within a defined area or "footprint.”
  • the articulation component 106 is free to translate in the x-y plane and rotate on the z-axis within the footprint of the base component 108 up to the position where an edge of the articulation component 106 encounters a post.
  • Posts 150 can be sized and shaped the same or can have varying sizes or shapes depending on the forces anticipated to be applied at a particular location. Furthermore, the articulation component 106 can be shaped to correspond to the amount of rotation and translation that is desired in each particular direction. In a preferred embodiment, the articular component 106 can rotate, about the z-axis, without physical constraint between about -30 degrees and +30 degrees with respect to the base component 108, and can translate between about -10 and +10 mm in the x-y plane before engagement with the peripheral stop. Persons of ordinary skill in the art may utilize other types or designs for mechanical stops without departing from the invention.
  • the stops can be constructed from a hard material, an elastic material, a viscoelastic material that dissipates some impact energy upon contact, or the like. Furthermore, the number, shape, and size of the stops can be arranged to increase the surface area for impact. Therefore, distributing the impact forces over a larger surface area minimizes the impact forces being concentrated at any one point and, thereby reducing mechanical loosening or other damage.
  • structural magnetic stops 250 protrude from base component 108 forming a perimeter barrier past which articulation component 106 can not proceed.
  • the structural magnetic stops 250 include hard magnetic material 270 disposed on or within a protruding structure such as posts 260.
  • the protruding structure can be part of base component 108 or a housing that receives base component 108.
  • the magnetic field of hard magnetic material 270 is directed inward, toward the center of the footprint within which articulation component 106 is free to translate a predetermined amount in the x-y plane and rotate in the z-axis.
  • Articulation component 106 also includes hard magnetic material 280 at or near its perimeter.
  • Hard magnetic material 280 of articulation component 106 is configured to present a repulsive magnetic field with respect to hard magnetic material 270 at stops 260. In use, the repulsive magnetic fields between the two sets of hard magnetic material act to dissipate the impact energy between the articulation component 106 and the stops 250 such that there is less stress on the components and lower transmission of shock to the bone.
  • FIG. 2 illustrates one embodiment incorporating each of the embodiments of FIGS. 1A - ID.
  • Articular component 106 includes hard magnetic material 112 at its center and further hard magnetic material 112a at the periphery.
  • the peripheral hard magnetic material may be continuous or intermittent.
  • Base component 108 includes central soft magnetic material 110 and patterned soft magnetic material 110a as described above.
  • Structural stops 108a include hard magnetic material 112b arranged to repulse hard magnetic material 112a on articular component 106.
  • mobile bearing 101 is located between articular component 106 and tibial stem 104.
  • Soft magnetic material 110 is embedded directly within tibial stem 104, for example in the tibial plate. This embodiment reduces the number of components in the prosthesis.
  • mobile bearings may be implemented at different levels and/or at multiple levels within a prosthetic component.
  • prosthesis 200 is a prosthesis for a shoulder joint adapted with two magnetic coupler mobile bearings 201 and 207.
  • the humeral stem 202 connects to humeral base component 204 with a conventional attachment, for example a Morse taper.
  • Humeral base component 204 contains soft magnetic material 110 embedded therein.
  • the humeral articulation component 206 is configured to articulate with the opposing articulation surface of the total or partial joint arthroplasty and is embedded with hard magnetic material 112. It is preferable that the hard magnetic material 112 be positioned to oppose the soft magnetic material 110 embedded within the base component.
  • a mobile bearing 201 such as that described with respect to FIG. 1 A, is established.
  • Second mobile bearing 207 may be provided for additional energy dissipation and to permit displacement in another plane.
  • the glenoid articulation component 208 contains hard magnetic material 112. Adjacent to the glenoid articulation component 208 is the scapula base component 210.
  • FIG. 5 shows a further alternative embodiment of hard magnetic material 112 and soft magnetic material 110 embedded within articulation components 106 and base components 108, respectively.
  • the articulation and base components are depicted as not joint specific and can be adapted for placement at any level or multiple levels in any joint replacement.
  • hard magnetic material 112 is embedded within the articulation component 106.
  • hard magnetic material 112 is a solid unit comprising a continuous permanent magnet, such that a shaped uniform magnetic flux is produced.
  • embedded within base component 108 is soft magnetic material 110.
  • soft magnetic material 110 is preferably dispersed in an annular manner substantially located around the perimeter of the base component 108. This creates a footprint in the central region in which there is little or no attractive force between hard magnetic material 112 in articulation component 106 and soft magnetic material 110 in base component 108. As long as hard magnetic material 112 is located within this foot print, articulation component 106 can move relatively freely. However, a gradient of increasing force is created as the articulation component 106 moves substantially beyond the foot print. As hard magnetic material 112 moves closer to alignment with soft magnetic material 110, or toward the edge of the foot print, the magnetic force attracts the two components and gradually reduces or stops the movement of the articulation componentl06.
  • hard magnetic material 112 is configured in a shaped or step manner, such that the magnet surface is closer to soft magnetic material 110 at some locations and spaced farther away in other locations.
  • the portions of the magnet that are closer, in the z-axis direction, to soft magnetic material 110 will have a stronger magnetic attraction than the portions that are farther away from soft magnetic material 110. Therefore, a dynamic constraint gradient is formed in the coupler mobile bearing 101 of this embodiment.
  • the hard or soft magnetic material may be distributed in a wide variety of patterns.
  • FIG. 6 A shows a plan view of one such distribution of hard magnetic material 402A-402F embedded within the articulation component 106.
  • the pattern of material 402A-402F affects the relative amounts of overlapping surface areas between hard and soft magnetic material.
  • the strength of magnetic attraction is proportional to that overlapping surface area. Therefore, the strength of the dynamic constraint between articulation component 106 and base component 108 changes as articulation component 106 moves relative to base component 108.
  • the gradient can be linear, non-linear, symmetric, or non- symmetric.
  • the hard magnetic material is dispersed in a pattern that is symmetric or asymmetric and the soft magnetic material 110 is a solid unit.
  • the soft magnetic material 110 is arranged in a distribution as described above and the hard magnetic material 112 is configured as a solid unit.
  • both hard and soft magnetic materials may be provided in a desired distribution pattern.
  • FIG. 6B illustrates a further alternative embodiment in which the magnetic material is further overlapped. The further overlapping of material 404A-404L embedded within the articulation component 106 creates a greater magnetic force and thereby a stronger dynamic constraint gradient between the respective articulation component 106 and base component (not shown). In use, the amount of overlapping material can be adjusted to substantially match the magnitude and direction of forces to be absorbed into the system.
  • hard magnetic materials 112 may be constrained to a single solid unit and soft magnetic material 110 is varied in size, shape, and configuration according to the above descriptions, and the like. In use, varying the soft magnetic material 110 will produce the same resulting dynamic constraint mobile bearing as that described above. It is further stressed that soft magnetic material 110 of the base component 108 can be substituted with hard magnetic material, such that hard magnetic materials 112 of the articulation component 106 spatially oppose and magnetically attract or repel the hard magnetic material in the base component 108. In use, this forms a dynamic constraint mobile bearing system equivalent to the systems described above.
  • FIG. 6C shows an alternative embodiment to the overlapping magnetic material of FIGS. 6 A and 6B.
  • material 406A-406L embedded within the articulation component 106.
  • material 406A-406L can be either hard magnetic material or soft magnetic material and can oppose either solid units or symmetric or asymmetric patterns of hard or soft magnetic material in the opposing component of the mobile bearing.
  • Material 406A-406L primarily increases in cross sectional area as the distance increases away from the center of the articulation component 106.
  • the base component 108 (not shown) contains either hard magnetic material or soft magnetic material.
  • the attractive force of the magnetic material 406A-406L increases corresponding to the increasing surface area overlap between the magnetic material 406A-406L of the articulation component 1-6 and the hard or soft magnetic material in the base component (not shown).
  • the hard magnetic material may be configured as a ring, e.g., ring array magnet 800 (opposite sides of which are shown in cross section in FIG. 7A).
  • Articular component 850 provides articular surface 854, which cooperates with femoral component 856, and encompasses ring array magnet 800.
  • Articular component 850 also defines recessed portion 853.
  • the base component and tibial attachment component are combined in a single, tibial component 852. As will be appreciated, these components may be separately provided as described above.
  • Locator pin 855 extends from tibial component 852 and is received in recessed portion 853 of the articular component.
  • locator pin 855 includes hard magnetic material 858 with polarity directed radially outward away from locator pin 855.
  • Ring array magnet 800 is preferably configured such that the magnetic flux is oriented towards the center of the ring. Ring array magnet 800 and the hard magnetic material 858 embedded within locator pin 855 thus preferably cooperate such that the magnetic flux emanating from the ring opposes the magnetic flux emanating from the hard magnetic material 858 embedded within locator pin 855. Therefore, the articulation component 850 moves freely in the medial and lateral directions up to the point where the opposing magnetic fluxes begin to interact. It is preferred that the locator pin be rounded in shape with a long axis greater than about 10 millimeters in diameter and less that 80 percent of the surface area of the mobile bearing.
  • the receiving hole for the locator pin is preferred to be roughly 3 millimeters larger than the diameter of the locator pin. It is more preferred that the locator pin be elliptical in shape with the larger radius of curvature be positioned to intercept the direction of movement carrying the largest energy loads. For example, in the knee joint the larger radius of . curvature of an elliptical locator pin are positioned toward the anterior and posterior. This provides a larger surface area for contact between the component and the locator pin which in turn reduces the stresses at any given point, thereby, reducing mechanical failure.
  • the magnetic fluxes disperse momentum of the motion and gradually retards the motion between the tibial component 852 and the articulation component 850. In use, this relieves the joint articulation surface of the prosthesis of forces that typically induce wear debris, mechanical loosening, material deformation of the articulation surfaces, and the like. Furthermore, because the magnetic fluxes of the ring 800 and the hard magnetic material 858 embedded within locator pin 855 oppose each other, the articulation component 850 is magnetically assisted in repositioning to a preferred position with respect to the tibial component 852 following displacement by a force. Locator pin 855 also may be configured to provide a mechanical stop at the desired limit of travel by abutting against the edge of recessed portion 853.
  • tibial component 852 may be incorporated into tibial component 852 to interact with ring magnet 800 in a manner as described above in connection with the various embodiments.
  • additional magnetic elements will further increase the stability of the device as compared to prior art pin devices.
  • the locator pin 855 may be replaced with a magnetic field emanating from hard magnetic material 860 embedded flush or recessed within tibial component 852, FIG. 7B.
  • the ring array magnet 800 is prevented from translating too far in any direction on the x-y plane by repulsion from the magnetic field emanating from the material embedded within the tibial component 852.
  • hard magnetic material embedded within the prosthesis may be configured with regions of altering magnetic polarity.
  • upper magnetic unit 910 is embedded within one component of a prosthesis, such as, the articulation component 106 (e.g., FIG. 1A) and lower magnetic unit 920 is embedded within another portion of the prosthesis, such as, the tibial component, thereby forming a magnetic coupler mobile bearing as previously described.
  • hard magnetic material 902 is positioned opposite and adjacent to hard magnetic material 904. The polarity of the adjacent hard magnetic material 902 and 904 alters from the north pole of the hard magnetic material being oriented in a negative z-axis direction to the north pole of the magnet being oriented in a positive z-axis direction, respectively, as shown in the figure. The adjacent magnets thus create alternating magnetic potential wells and potential hills.
  • the upper and lower magnetic units 910 and 920 can translate with respect to each other.
  • the attractive magnetic forces of the upper and lower magnetic units 910 and 920 become weakened.
  • the amount of attractive force corresponds to the amount of overlapping surface area between the magnets 902 and 904 of the upper magnetic unit 910 with magnets 902 and 904 of the lower magnetic unit 920.
  • the magnetic coupler 901 is unstable and the upper and lower magnetic units 910 and 920 will move to the next attractive orientation in the direction of the force.
  • the units cycle as they move in the x-axis direction from attractive to repulsive configurations. This is equivalent to deepening the potential wells of the attractive configurations.
  • This attractive/repulsive configuration of the magnetic elements dissipates the momentum by introducing an alternate wave of potential well to potential hills, introducing a form of an alternating braking mechanism.
  • the magnetic material 902 and 904 can have different intrinsic strengths or shapes to generate a functional end pattern applicable to the particular location or patients requirements.
  • the magnetic coupler 901 absorbs and dissipates energy input into the prosthesis, such as shear forces, as the upper magnetic unit 910 moves relative to the lower magnetic unit 920.
  • the upper magnetic unit 910 can rotate about the z-axis and with respect to the lower magnetic unit 920, as illustrated in FIG. 9. (FIG. 9 also shows upper and lower magnetic units with a larger number of adjacent bar magnets 902 and 904). Upon rotation, the force of magnetic attraction between the upper and lower magnetic units 910 and 920 corresponds to the amount of overlapping surface area of the attractive and repellant linear hard magnetic material 902 and 904 effectively making the potential well less steep.
  • the magnetic coupler 901 disperses rotational energy about the z-axis into the magnetic flux of the magnetic units 910 and 920.
  • the arrangement dissipates force energy that typically leads to destructive events within a joint prosthesis.
  • the magnetic coupler 901 allows the articulation surfaces of the joint prosthesis to remain congruent following a rotational input force because the magnetic coupler 901 dissipates the rotational force, rotates, and returns to the orientation of greatest magnetic attraction when the rotational force is removed.
  • hard magnetic materials 112 of mobile bearing 101 comprise multiple hard magnetic material magnets coupled together in a grid pattern 1100, also referred to as a unit of a stepper 1100, as shown in FIG 10.
  • a grid pattern 1100 also referred to as a unit of a stepper 1100, as shown in FIG 10.
  • Within the grid pattern 1100 there are regions of north and south oriented polarities. An alternating field of magnetic potential wells and hills is thus formed effectively deepening the potential wells.
  • a pair of matching grid patterns 1100 positioned opposite each other forms a stepper type mobile bearing 101. Portions of the grid 1100 produce a region of northern oriented polarity and other portions generate a southern oriented polarity.
  • Repetitive base unit 1130 is composed of individual magnets arranged such that the magnetic polarity of each magnet is oriented in directions that cause the magnetic flux to add and concentrate on one surface of the repetitive base unit 1130, while making the field substantially zero on the opposite side. This effectively doubles the magnetic field strength for the same given mass of hard magnetic material.
  • repetitive base unit 1130 is generally composed of four magnets 1132, 1134, 1136 and 1138.
  • the magnets in the base units 1130 oriented along the x-axis direction have magnetic polarities where magnet 1132 is oriented in the positive z-axis direction and the magnetic polarity of magnet 1134 is oriented in the negative x-axis direction, whereas the magnetic polarity of magnet 1136 is oriented in the negative z-axis direction and the magnetic polarity of magnet 1138 is oriented in the positive x-axis direction.
  • Multiple base units 1130 are aligned linearly along the x-axis direction and also along the y-axis direction. The linear alignment of the multiple base units 1130 cross or overlap each other.
  • Magnet 1132 abuts magnet 1138 of another base unit 1130, and so on.
  • the multiple base units 1130 are interlaced by co-using magnet 1136 in both the x-axis and y-axis oriented base units 1130.
  • the grid pattern shown in FIG. 10 is formed.
  • the spaces 1140 are composed of nonmagnetic material such as ceramic, metal, or plastic, a suitable example being ultra high molecular weight polyethylene, or the like.
  • the non-magnetic material may be substituted with a ferrous material that is suitable for implantation into the body.
  • a first grid 1100 A is embedded within articulation component
  • the articulation component 106 translates in the x-y plane and can rotate about the z-axis with respect to the base unit 108 when an force is applied to the mobile bearing 101.
  • the component moves as the magnets move within their potential wells.
  • the components remain relatively stationary with respect to one another until the force applied is greater than the cumulative potential well force.
  • the magnitude of the force applied to the system and the overall strength of the magnetically bound steppers through the magnitude and quantity of magnets 1132, 1134, 1136, and 1138 will determine how much movement is attained between components 106 and 108 in response to a given force.
  • the binding, dislodging, and binding dissipates force input into the mobile bearing 101 system. It is preferred that following the removal of the force, the combined magnetic binding force of magnets 1136 with magnets 1132 is not so great that the anatomical features of the respective joint cannot realign the first and second grids 1100A and 1100B and therefore the articulation component 106 with the base component 108 to an equilibrium position.
  • the second grid 1100B is replaced with ferrous or other magnetic material that corresponds to the spacing of the attractive magnetic flux of the first grid 1100 A.
  • the magnetic material is magnetically bound to the first grid 1100A at the attractive magnetic flux regions, thereby forming a mobile bearing magnetic coupler.
  • stepper can be of many variable configurations.
  • FIG. 12 illustrates a further variation of the structural stop described above.
  • perimeter barrier stop 170 fully surrounds the articulation component 106.
  • Perimeter barrier stop 170 can be an extension of the base component 108 or it can be a separate component that houses the base component 108.
  • the surfaces of the components 106 and 108 that interact with one another are highly polished surfaces 106A and 108B, respectfully.
  • the articulation component 106 can translate in the x-y plane and rotate around the z-axis a predetermined amount depending on the tolerance between the perimeter of the articulation component 106 and the perimeter barrier stop 170. This embodiment provides even greater contact area at the edges to increase dissipation of loads.
  • FIG. 13 shows a further alternative embodiment of the mobile bearing
  • the movement between the articulation component 106 and the base component 108 is limited to particular x-y plane translation and rotation around the z-axis.
  • the surface of the articulation component that is opposite the articulation surface 114 protrudes and is received by a recess in the mating surface of the base component 108.
  • the articulation component 106 can translate in the x-y plane and rotate in the z-axis a predetermined amount depending on the tolerance between the protrusion 107 and the recess 109.
  • FIG. 14 illustrates another embodiment in which base component 108 of mobile bearing 101 is configured with hard magnetic material 350 oriented around its perimeter.
  • Hard magnetic material 350 is completely encased within the base component 108 and configured with its magnetic field represented by the arrow.
  • the magnetic field forms a perimeter barrier defining a footprint where the articulation component 106 is free to translate in the x-y plane and rotate around the z-axis.
  • the articulation component 106 contains hard magnetic material 360 around or near its perimeter.
  • the hard magnetic material 360 encased within the articulation component 106 has its magnetic field directed, as shown by the arrow, toward the perimeter of the base component 108.
  • the translation and rotation is dampened and preferably dissipated when the opposing magnetic fields intersect, urging the mobile bearing to an equilibrium position. This creates a magnetic perimeter barrier past which the articulation component 106 cannot pass.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Neurology (AREA)
  • Transplantation (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Radiology & Medical Imaging (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne une prothèse comprenant au moins un premier composant et un second composant. Ces composants sont disposés avec une variété de matières magnétiques. Cette matière magnétique est soit une matière magnétique dure ou une matière magnétique molle. Cette matière magnétique est agencée et conçue pour interagir de manière magnétique et de manière contrôlable pour un déplacement contraint entre les composants. Cette manière magnétique est également organisée pour générer un gradient contre le déplacement des composants. Cette matière magnétique forme des motifs de grille opposées en interverrouillage magnétique.
PCT/US2004/012665 2003-04-21 2004-04-21 Protheses de support mobiles Ceased WO2004093732A2 (fr)

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Application Number Priority Date Filing Date Title
US10/420,648 US20030187510A1 (en) 2001-05-04 2003-04-21 Mobile bearing prostheses
US10/420,648 2003-04-21

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WO2004093732A2 true WO2004093732A2 (fr) 2004-11-04
WO2004093732A3 WO2004093732A3 (fr) 2005-02-17

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WO (1) WO2004093732A2 (fr)

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